The content of this evidence summary was up-to-date in March 2013. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information.
Racecadotril received a UK marketing authorisation in September 2011 and was launched in the UK in October 2012. It has been licensed in parts of Europe for some time, for example in France for more than 20 years.
Racecadotril is licensed for the symptomatic treatment of acute diarrhoea in adults. It is also licensed for the complementary symptomatic treatment of acute diarrhoea in infants (aged over 3 months) and in children together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition. Use in children is the subject of a separate evidence summary.
This evidence review is based on the 2 studies comparing racecadotril with loperamide for treating acute diarrhoea in adults. Both of these studies suggest that racecadotril and loperamide are similarly effective in reducing the duration of diarrhoea and the number of stools produced, and racecadotril has fewer adverse effects than loperamide, particularly constipation and abdominal distension. However, both studies have limitations affecting their validity and application to UK practice.
One of these 2 studies (Prado 2002; n=945) found that the mean duration of diarrhoea was 55 hours in both the racecadotril and loperamide groups (no significant difference). Significantly more patients in the loperamide group experienced constipation (25% compared with 16%, p=0.001). This study was undertaken in 14 countries outside Europe, where the aetiology and severity of diarrhoea is likely to differ from the UK, which limits its applicability to UK practice.
The second study (n=157) was undertaken in France by Vetel et al. (1999). It found that the mean number of stools passed until recovery and the mean duration of diarrhoea were similar with racecadotril and loperamide (3.5 compared with 2.9, and 14.9 hours compared with 13.7 hours respectively). The statistical significance of the difference between the groups was not given. The incidence of constipation was higher among patients treated with loperamide (18.7% compared with 9.8%) but this difference was not statistically significant.
Racecadotril appears to be well tolerated. The adverse effect most commonly reported is headache.
Local decision makers will need to consider the available evidence when making decisions about using racecadotril.
Prado D (2002) A multinational comparison of racecadotril and loperamide in the treatment of acute watery diarrhoea in adults. Scandinavian Journal of Gastroenterology 37: 656–61
Vetel JM, Berard H, Fretault N et al. (1999) Comparison of racecadotril and loperamide in adults with acute diarrhoea. Alimentary Pharmacology and Therapeutics 13 (Suppl. 6): S21–6
'Evidence summaries: new medicines' provide summaries of key evidence for selected new medicines, or for existing medicines with new indications or formulations, that are considered to be of significance to the NHS. The strengths and weaknesses of the relevant evidence are critically reviewed within this summary to provide useful information for those working on the managed entry of new medicines for the NHS, but this summary is not NICE guidance.